Healthy Skepticism Library item: 11740
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Damle A, Lurie P, Wolfe SM.
A Policy Study of Clinical Trial Registries and Results Databases
Public Citizen Health Research Group Publications 2007 Jul 17
http://www.citizen.org/publications/release.cfm?ID=7534#Results
Abstract:
As evidence that pharmaceutical companies have suppressed unfavorable study results has grown, the need for publicly available clinical trial registries and results databases has gained increasing public currency.1 In one example of selective publication, industry-funded academic scientists withheld from publication certain studies of the Selective Serotonin Reuptake Inhibitor antidepressants that failed to demonstrate drug efficacy.2 Had these studies been published, the known risk-benefit profile of the drugs would have been altered.3 In another revealing example, the Journal of the American Medical Association published a report in 2001 claiming that, after six months of therapy, the COX-2 inhibitor celecoxib (Celebrex) was associated with a reduced incidence of gastrointestinal ulcers compared to two older pain medications.4 However, the authors of the study failed to disclose that at the time of publication they had already received data covering a twelve-month period – the planned duration of the study.5 The twelve-month data showed no advantage with respect to gastrointestinal toxicity for Celebrex over the other drugs. These two cases underscore the dangers of pharmaceutical companies withholding data from physicians and patients. Online databases have been put forth as a potential solution to these sorts of selective publication.
In this report, we distinguish between two sorts of databases…
